Quality Improvement Guidelines for Percutaneous Transhepatic Cholangiography, Biliary Drainage, and Percutaneous Cholecystostomy PDF

Standards of Practice Quality Improvement Guidelines for Percutaneous Transhepatic Cholangiography, Biliary Drainage, and Percutaneous Cholecystostomy Wael E. A. Saad, MD, Michael J. Wallace, MD, Joan C. Wojak, MD, Sanjoy Kundu, MD, and John F. Cardella, MD J Vasc Interv Radiol 2010; 21:789 –795...

Standards of Practice Quality Improvement Guidelines for Percutaneous Transhepatic Cholangiography, Biliary Drainage, and Percutaneous Cholecystostomy Wael E. A. Saad, MD, Michael J. Wallace, MD, Joan C. Wojak, MD, Sanjoy Kundu, MD, and John F. Cardella, MD J Vasc Interv Radiol 2010; 21:789 –795 PREAMBLE Technical documents specifying the (Appendix A). For purposes of these exact consensus and literature review documents consensus is defined as THE membership of the Society of In- methodologies as well as the institu- 80% Delphi participant agreement on terventional Radiology (SIR) Stan- tional affiliations and professional cre- a value or parameter. dards of Practice Committee represents dentials of the authors of this docu- The draft document is critically re- experts in a broad spectrum of interven- ment are available upon request from viewed by the Revisions Subcommittee tional procedures from both the private SIR, 3975 Fair Ridge Dr., Suite 400 N., members of the Standards of Practice and academic sectors of medicine. Gen- Fairfax, VA 22033. Committee, either by telephone confer- erally Standards of Practice Committee ence calling or face-to-face meeting. The members dedicate the vast majority of finalized draft from the Committee is their professional time to performing in- METHODOLOGY sent to the SIR membership for further terventional procedures; as such they input/criticism during a 30-day com- represent a valid broad expert constit- SIR produces its Standards of Prac- ment period. These comments are dis- uency of the subject matter under tice documents using the following cussed by the Subcommittee, and ap- consideration for standards produc- process. Standards documents of rele- propriate revisions made to create the tion. vance and timeliness are conceptual- finished standards document. Prior to ized by the Standards of Practice Com- its publication the document is en- mittee members. A recognized expert dorsed by the SIR Executive Council. From the Division of Vascular Interventional Radi- is identified to serve as the principal ology, Department of Radiology (W.E.A.S.), Univer- author for the standard. Additional sity of Virginia Health System, Charlottesville, Vir- authors may be assigned dependent ginia; Department of Radiology (M.J.W.), The INTRODUCTION University of Texas M. D. Anderson Cancer Center, upon the magnitude of the project. Houston, Texas; Department of Radiology (J.C.W.), An in-depth literature search is per- Percutaneous transhepatic cholan- Our Lady of Lourdes Medical Center, Lafayette, formed using electronic medical liter- giography is a safe and effective tech- Louisiana; Department of Medical Imaging (S.K.), ature databases. Then a critical review nique for evaluating biliary abnormal- Scarborough General Hospital, Scarborough, On- tario, Canada; and Department of Radiology (J.F.C.), of peer-reviewed articles is performed ities. It reliably demonstrates the level Geisinger Health System, Danville, Pennsylvania. with regards to the study methodol- of abnormalities and sometimes can Received December 15, 2009; final revision received ogy, results, and conclusions. The help diagnose their etiologies. Percuta- January 3, 2010; accepted January 13, 2010. Address qualitative weight of these articles is neous transhepatic biliary drainage is an correspondence to W.E.A.S., c/o Debbie Katsarelis, SIR, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA assembled into an evidence table, effective method for the primary or pal- 22033 E-mail: [email protected] which is used to write the document liative treatment of many biliary abnor- such that it contains evidence-based malities demonstrated with cholangiog- M.J.W. has received research funding from Siemens Medical Solutions (Iselin, New Jersey). None of the data with respect to content, rates, and raphy. Percutaneous cholecystostomy is other authors have identified a conflict of interest. thresholds. an effective method for decompressing When the evidence of literature is the gallbladder for managing cholecys- An earlier version of this article appeared in J Vasc Interv Radiol 1997; 8:677– 681; and was reprinted in weak, conflicting, or contradictory, titis either definitively or as a temporiz- J Vasc Interv Radiol 2003; 14(Suppl):S243–S246. consensus for the parameter is reached ing measure before cholecystectomy. by a minimum of 12 Standards of These guidelines are written to be © SIR, 2010 Practice Committee members using a used in quality improvement pro- DOI: 10.1016/j.jvir.2010.01.012 modified Delphi consensus method grams to assess percutaneous transhe- 789 790 QI Guidelines: Cholangiography, Biliary Drainage, Cholecystostomy June 2010 JVIR patic cholangiography, biliary drain- Table 1 Table 3 age, and cholecystostomy. The most Percutaneous Transhepatic Percutaneous Cholecystostomy: important processes of care are (i) pa- Cholangiography: Indications (1– 6) Indications (11–27) tient selection, (ii) performing the proce- dure, and (iii) monitoring the patient. Define level of obstruction in patients Gallbladder access (⬎95%)* The outcome measures or indicators with dilated bile ducts Management of cholecystitis for these processes are indications, Evaluate for presence of suspected Portal for dissolution/removal of bile duct stones stones success rates, and complication rates. Determine etiology of cholangitis Biliary tract access (⬍5%)* Outcome measures are assigned thresh- Evaluate suspected bile duct Decompress obstructed biliary tract old levels. inflammatory disorders Divert bile from bile duct defect Demonstrate site of bile duct leak Provide a portal of access to the DEFINITIONS Determine etiology of transplanted biliary tract for therapeutic hepatic graft dysfunction purposes (see Table 2) Percutaneous transhepatic cholan- *The thresholds for gallbladder and giography is a diagnostic procedure that transcholecystic biliary tract access are involves the sterile placement of a small- 95% and 5%, respectively. When this gauge needle into peripheral biliary ratio for these indications is different, Table 2 radicles with use of imaging guidance, Percutaneous Transhepatic Biliary the department will review the process followed by contrast material injection Drainage: Indications (7–10) of patient selection. The first-line route to delineate biliary anatomy and poten- for percutaneous biliary tract access is tial biliary pathologic processes. The Provide adequate biliary drainage the transhepatic route and not the findings are documented on radio- Decompress obstructed biliary tree transcholecystic route. Divert bile from and place stent in graphs obtained in multiple projec- bile duct defect tions. Percutaneous transhepatic biliary Provide a portal of access to the biliary drainage is a therapeutic procedure tract for therapeutic purposes that that includes the sterile cannulation include but are not limited to than 95% of procedures are for these of a peripheral biliary radicle after Dilate biliary strictures indications, the department will review percutaneous puncture followed by Remove bile duct stones the process of patient selection. imaging-guided wire and catheter ma- Stent malignant lesions Currently, metal stents are used almost nipulation. Placement of a tube or stent Brachytherapy/phototherapy exclusively for malignant disease. How- for external and/or internal drainage Endoluminal tissue sample or ever, the committee recognizes that cov- completes the procedure. Percutaneous foreign body retrieval ered metal stent (or stent-graft) placement Provide a portal of access to the biliary for benign strictures with the intent of therapy of biliary lesions is often staged, tract for mid- to long-term requiring several sessions to achieve the subsequent retrieval is a potentially new diagnostic purposes (lower-risk therapeutic goals. Percutaneous chole- cholangiography*) indication, although the results of this are cystostomy is a therapeutic procedure still inconclusive. that involves the sterile placement of a *Cholangiography from an Gallbladder decompression for the needle into the gallbladder with use of indwelling percutaneous biliary drain management of cholecystitis can be per- imaging guidance to aspirate bile. This site is probably a lower-risk formed with the intent of definitive cholangiography procedure than therapy in patients at high risk with is commonly followed by sterile place- repetitive de novo percutaneous ment of a tube for external drainage of medical comorbidities or as a tempo- transhepatic cholangiography with gallbladder contents, which completes the use of needles. rizing measure augmenting medical the procedure. treatment and preceding a subse- Successful percutaneous transhe- quent, more elective, cholecystec- patic cholangiography is defined as tomy. The decision of whether to sufficient needle localization and con- therapy or a short hospital stay for proceed with cholecystectomy (in a trast material opacification to allow observation (generally overnight; see surgical candidate) or consider per- image-based diagnosis or planning of Appendix B). The complication rates cutaneous cholecystostomy a defini- treatment. Successful biliary drainage and thresholds described herein refer tive measure (in a nonsurgical candi- or cholecystostomy is defined as the to major complications unless other- date) is usually multidisciplinary (ie, placement of a tube or stent with use wise specified. surgical, anesthesiology, and radiology) of imaging guidance to provide con- and depends on patients’ response to tinuous drainage of bile. therapy. Complications can be stratified on INDICATIONS AND Coagulopathy is a relative contrain- the basis of outcome. Major complica- CONTRAINDICATIONS dication to percutaneous transhepatic tions result in admission to a hospital cholangiography, biliary drainage, and for therapy (for outpatient proce- Indications for percutaneous transhe- percutaneous cholecystostomy. Every dures), an unplanned increase in the patic cholangiography, percutaneous effort should be made to correct or im- level of care, prolonged hospitaliza- transhepatic biliary drainage, and chole- prove coagulopathy before the proce- tion, permanent adverse sequelae, or cystostomy are listed in Tables 1–3, re- dure. In patients with persistent coagu- death. Minor complications result in spectively (1–27). The threshold for lopathy, these procedures may still be no sequelae; they may require nominal these indications is 95%. When fewer indicated if they are associated with a Volume 21 Number 6 Saad et al 791 Table 4 Table 5 Percutaneous Transhepatic Percutaneous Transhepatic Biliary Drainage: Success Rates (9,28 – 41) Cholangiography: Success Rates (1– 4) Outcome Threshold (%) Outcome Threshold (%) Procedural success after opacification by PTC Opacify dilated ducts 95 Cannulation Opacify nondilated 65 Dilated ducts 95 ducts Nondilated ducts 70 Internal drainage (tube or stent) 90* Stone removal (9,34) 90 Patency success lower expected morbidity rate than al- Stricture dilation (benign) ternative methods of diagnosis or treat- Sclerosing cholangitis (35–37) † Other (35,38–41) † ment. Palliative stents for malignant disease (28–33) 50 (at 6 mo) QUALITY IMPROVEMENT Note.—PTC ⫽ percutaneous transhepatic cholangiography. *Among successful cannulations. Although practicing physicians should †Consensus for threshold not reached (see Appendix A). strive to achieve perfect outcomes (eg, 100% success, 0% complications), in practice all physicians will fall short of this ideal to a variable extent. Thus, in- Table 6 dicator thresholds may be used to assess Percutaneous Cholecystostomy: Success Rates (19,42–59) the efficacy of ongoing quality improve- Outcome Threshold (%) ment programs. For the purposes of these guidelines, a threshold is a specific Procedural success for aspiration of gallbladder contents (19,42–44) level of an indicator that should prompt Technical success* a review. “Procedure thresholds” or 21-gauge needle 80 “overall thresholds” reference a group 18-gauge needle 95 of indicators for a procedure (eg, major Clinical success† Single aspiration 50 complications). Individual complications Multiple (n ⫽ 2–3) aspirations 80 may also be associated with complication- Procedural success for cholecystostomy drain placement (45–59) specific thresholds. When measures such Technical success 90 as indications or success rates fall below Intent-to-treat clinical success† 65 a minimum threshold or when compli- Cholecystostomy as definitive treatment in the sick (high risk of cation rates exceed a maximum thresh- morbidity) old, a review should be performed to With cholecystectomy or repeat cholecystostomy resorted to as 75 determine causes and to implement needed changes, if necessary. For example, if the Cholecystostomy for acalculous cholecystitis 65 incidence of sepsis is one measure of the Cholecystostomy for calculous cholecystitis 75 quality of percutaneous transhepatic *Greater than 95% of failures resulted from thick aspirate and not failure to access cholangiography, values in excess of the gallbladder under image guidance (19,42– 44). defined threshold should trigger a re- †Clinical success based on reduction of pain, fever, white blood cell count, and C- view of policies and procedures within reactive protein (19,42–59). the department to determine the causes and to implement changes to lower the incidence for the complication. Thresh- olds may vary from those listed here; for and will increase the success rate of the listed in Tables 4 – 6, respectively (1– example, patient referral patterns and procedure. Close follow-up, with moni- 4,9,19,28 –59). selection factors may dictate a different toring and management of patients who Clinical success rate of cholecystos- threshold value for a particular indica- have undergone percutaneous transhe- tomy in a particular practice depends tor at a particular institution. Thus, set- patic cholangiography, biliary drainage, on patient selection. Patients’ comor- ting universal thresholds is very diffi- and cholecystostomy, is appropriate for bidity, the proportion of patients with cult, and each department is urged to the radiologist. cholelithiasis, and whether the prepro- alter the thresholds as needed to in- cedural diagnosis of cholecystitis is crease or decrease values to meet its correct affect results. Having a low SUCCESS RATES AND own quality improvement program threshold for diagnosing cholecystitis THRESHOLDS needs. in inpatients potentially increases the Participation by the radiologist in pa- Success rates for percutaneous tran- rate of false positive cholecystitis, and tient follow-up is an integral part of per- shepatic cholangiography, percutane- in turn this reduces the success rate cutaneous transhepatic cholangiography, ous transhepatic biliary drainage, of cholecystostomy. Positive microbial biliary drainage, and cholecystostomy and percutaneous cholecystostomy are culture of gallbladder aspirate has 792 QI Guidelines: Cholangiography, Biliary Drainage, Cholecystostomy June 2010 JVIR been reported in between 40% and Table 7 80% of cases (12,14,18,52,54,55,58 – 61). Percutaneous Transhepatic Cholangiography: Major Complications Reported Suggested Procedure COMPLICATION RATES Major Complication Rate (%) Threshold (%) Percutaneous Transhepatic Sepsis, cholangitis, bile leak, hemorrhage, 2 4 Cholangiography or pneumothorax When 21-gauge or smaller needles are used, the major and minor compli- Table 8 cations of percutaneous transhepatic Percutaneous Transhepatic Biliary Drainage: Major Complications cholangiography should be low. All (10,28 –30,32–33,64 – 66) patients should be treated with appro- priate antibiotics before needle punc- Reported Suggested Specific ture (1– 4,62,63). Complication rates Major Complication Rate (%) Threshold (%) are listed in Table 7. Intraprocedural Sepsis 2.5 5 Hemorrhage 2.5 5 Percutaneous Transhepatic Biliary Inflammatory/infectious (abscess, peritonitis, 1.2 5 Drainage cholecystitis, pancreatitis) Pleural 0.5 2 The complication rate for transhepatic Death 1.7 3 biliary drainage can be substantial, and Postprocedural varies with preprocedure patient status Inadvertent catheter discontinuation requiring de * * and diagnosis (Table 8) (10,28–30,32,33, novo PTC, death and/or surgery 64–66). Patients with coagulopathies, cholangitis, stones, malignant obstruc- Note.—PTC ⫽ percutaneous transhepatic cholangiography. tion, or proximal obstruction will have *There is no clear consensus in the literature on the rate of this complication. higher complication rates (9,32,65,67,68). However, it is a recognized postprocedural complication. Several authors have suggested that complications related to internal/ex- Table 9 ternal tubes as a result of inadequate Percutaneous Cholecystostomy: Major Complications (11–19,42,46 –50,52,54,58 –59) bile flow and tube dislodgment (sepsis and hemorrhage) can be minimized by Reported Suggested Specific placing a self-retaining tube of at least Major Complication Rate (%) Threshold (%) 10 F through the ampulla or anasto- Intraprocedural mosis (8,10,64). All patients should be Sepsis 2.5 5 treated with appropriate antibiotics Hemorrhage 2.2 5 before initiating the procedures to Inflammatory/infectious (abscess, peritonitis) 2.9 6 minimize septic complications (62,63). Transgression of adjacent structures (colon, 1.6 2 The duration of antibiotic therapy af- small bowel, pleura) ter the procedures will be determined Death 2.5 3 Postprocedural by the clinical course of individual pa- Inadvertent catheter discontinuation requiring ⬍1 2 tients. de novo cholecystostomy, death and/or Published rates for individual types surgery of complications are highly dependent on patient selection and are based on series comprising several hundred pa- tients, which is a volume larger than most individual practitioners are likely dure threshold for all major complications course of individual patients. Pub- to treat. Therefore, we recommend that of percutaneous transhepatic biliary lished rates for individual types of complication-specific thresholds be set drainage is 10%. complications are highly dependent at twice the complication-specific rates on patient selection and are based on listed in Table 8. It is also recognized series comprising tens of patients, Percutaneous Cholecystostomy which is a volume larger than most that a single complication can cause a rate to cross above a complication-spe- The complication rate for percuta- individual practitioners are likely to cific threshold when the complication neous cholecystostomy varies with treat. Therefore, we recommend that occurs in a small volume of patients (eg, preprocedure patient status (Table 9) complication-specific thresholds be set early in a quality improvement pro- (11–19,42,46 –50,52,54,58,59). All pa- at twice the complication-specific rates gram). In this situation, the overall pro- tients should be treated with appro- listed in Table 9. It is also recognized cedure threshold is more appropriate priate antibiotics, and the duration of that a single complication can cause a for use in a quality improvement pro- antibiotic therapy after the procedure rate to cross above a complication-spe- gram. The recommended overall proce- will be determined by the clinical cific threshold when the complication Volume 21 Number 6 Saad et al 793 occurs in a small volume of patients APPENDIX A: CONSENSUS References (eg, early in a quality improvement METHODOLOGY 1. Mueller PR, Harbin WP, Ferrucci JT Jr, program). In this situation, the overall et al. Fine-needle transhepatic cholan- procedure threshold is more appropri- Reported complication-specific rates in giography: reflections after 450 cases. ate for use in a quality improvement some cases reflect the aggregate of ma- AJR Am J Roentgenol 1981; 136:85–90. jor and minor complications. Thresh- 2. Butch RJ, Mueller PR. Fine-needle program. The recommended overall transhepatic cholangiography. Semin olds are derived from critical evaluation procedure threshold for all major compli- Intervent Radiol 1985; 2:1–20. of the literature, evaluation of empirical cations of percutaneous cholecystostomy 3. Harbin WP, Mueller PR, Ferrucci JT Jr. data from Standards of Practice Com- is 5% (sequelae of catheter dislodgment Complications and use patterns of fine- mittee members’ practices, and, when not included). The 30-day postprocedural available, the SIR HI-IQ System national needle transhepatic cholangiography: mortality rate depends on patient selec- a multi-institutional study. Radiology database. 1980; 135:15–22. tion/referral patterns and has a wide Consensus on statements in this range (8%–36%) depending on the popu- 4. Teplick SK, Flick P, Brandon JC. document was obtained utilizing a Transhepatic cholangiography in pa- lation presented (13,15,18,47,53,54,57). The modified Delphi technique (1,2). tients with suspected biliary disease vast majority of 30-day mortality cases are The Committee was unable to reach and nondilated intrahepatic bile ducts. related to patient comorbidities and not consensus on (i) the patency rate or Gastrointest Radiol 1991; 16:193–197. directly a cause of the procedure. threshold for dilation of strictures 5. Savader SJ, Benenati JF, Venbrux AC, Published rates for individual types caused by sclerosing cholangitis and et al. Choledochal cysts: classification of complications are highly depen- the (ii) patency rate or threshold and cholangiographic appearance. AJR dent on patient selection and are for dilation of benign strictures not Am J Roentgenol 1991; 156:327–331. based on series comprising several caused by sclerosing cholangitis. The 6. Craig CA, MacCarty RL, Wiesner RH, hundred patients, which is a larger failure to reach consensus was a result Grambsch PM, LaRusso NF. Primary volume than most individual practi- sclerosing cholangitis: value of cholan- of limited reported data and lack of giography in determining the progno- tioners are likely to treat. Generally agreement between reported data and sis. AJR Am J Roentgenol 1991; 157: the complication-specific thresholds the experiences of the committee 959 –964. should be set higher than the compli- members. 7. Nilsson U, Evander A, Ihse I, Lunder- cation-specific reported rates listed quist A, Mocibob A. Percutaneous here. It is also recognized that a single References transhepatic cholangiography and drain- complication can cause a rate to cross 1. Fink A, Kosefcoff J, Chassin M, Brook age. Acta Radiol 1983; 24:433– 439. above a complication-specific thresh- RH. Consensus methods: characteris- 8. Ferrucci JT Jr, Meuller PR, Harbin tics and guidelines for use. Am J Public WP. Percutaneous transhepatic bili- old when the complication occurs Health 1984; 74:979 –983. within a small patient series (eg, early ary drainage: technique, results, and 2. Leape LL, Hilborne LH, Park RE, et al. complications. Radiology 1980; 135: in a quality improvement program). In The appropriateness of use of coronary 1–13. this situation, an overall procedural artery bypass graft surgery in New York 9. Clouse ME, Stokes KR, Lee RGL, Fal- threshold is more appropriate for use State. JAMA 1993; 269:753–760. chuk KR. Bile duct stones: percutane- in a quality improvement program. In ous transhepatic removal. Radiology Table 9, all values are supported by APPENDIX B: SIR 1986; 160:525–529. the weight of literature evidence and STANDARDS OF PRACTICE 10. Mueller PR, vanSonnenberg E, Ferrucci panel consensus. COMMITTEE JT Jr. Percutaneous biliary drainage: technical and catheter-related prob- CLASSIFICATION OF lems in 200 procedures. AJR Am J Acknowledgments: Wael E. A. Saad, COMPLICATIONS BY Roentgenol 1982; 138:17–23. MD, authored the first draft of this revised OUTCOME 11. Lo LD, Vogelzang RL, Braun MA, document and served as topic leader dur- Nemcek AA Jr. Percutaneous chole- ing the subsequent revisions of the draft. Minor Complications cystostomy for the diagnosis and treat- Sanjoy Kundu, MD, is chair of the SIR Stan- ment of acute calculous and acalculous A. No therapy, no consequence. dards of Practice Committee and Michael cholecystitis. J Vasc Interv Radiol 1995; Wallace, MD, is the chair of the SIR Revi- B. Nominal therapy, no consequence; 6:629 – 634. sions Subcommittee. John F. Cardella, MD, includes overnight admission for 12. Hamy A, Visset J, Likholatnikov D, is Councilor of the SIR Standards Division. et al. Percutaneous cholecystostomy observation only. Other members of the Standards of Prac- for acute cholecystitis in critically ill tice Committee and SIR who participated Major Complications patients. Surgery 1997; 121:398 – 401. in the development of this revised clinical 13. England RE, McDermott VG, Smith TP, practice guideline are (listed alphabetical- C. Require therapy, minor hospital- Suhocki PV, Payne CS, Newman GE. ly): John F. Angle, MD, Daniel B. Brown, ization (⬍48 hours). Percutaneous cholecystostomy: who MD, Horacio R. D’Agostino, MD, Sanjeeva responds? AJR Am J Roentgenol 1997; P. Kalva, MD, Arshad Ahmed Khan, D. Require major therapy, unplanned 168:1247–1251. MD, Cindy Kaiser Saiter, NP, Marc S. increase in level of care, prolonged 14. Borzellino G, de Manzoni G, Ricci F, Schwartzberg, MD, Samir S. Shah, MD, hospitalization (⬎48 hours). Castaldini G, Guglielmi A, Cordiano C. Nasir H. Siddiqi, MD, LeAnn Stokes, Emergency cholecystostomy and sub- MD, Richard B. Towbin, MD, Aradhana E. Permanent adverse sequelae. sequent cholecystostomy for acute gall- Venkatesan, MD, and Darryl A. Zucker- stone cholecystitis in the elderly. Br J man, MD. F. Death. 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SIR DISCLAIMER The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles that generally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. A physician may deviate from these guidelines, as necessitated by the individual patient and available resources. These practice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care that are reasonably directed towards the same result. Other sources of information may be used in conjunction with these principles to produce a process leading to high quality medical care. The ultimate judgment regarding the conduct of any specific procedure or course of management must be made by the physician, who should consider all circumstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program will not assure a successful outcome in every situation. It is prudent to document the rationale for any deviation from the suggested practice guidelines in the department policies and procedure manual or in the patient’s medical record.